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CTRI Number  CTRI/2025/05/087912 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   a study to identify the risk factors of PCOS 
Scientific Title of Study
Modification(s)  		 A case-control study to assess the prevalence and risk factors of metabolic syndrome among females with and without PCOS in A tertiary care hospital, New Delhi 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satarupa Sarkar 
Designation  M.Sc. Nursing Student 
Affiliation  College Of Nursing, AIIMS Delhi 
Address  Pota cabin 2, 2nd floor, College of Nursing, AIIMS New Delhi 110049

South
DELHI
110049
India 
Phone  09679281700  
Fax    
Email  satarupa.sarkar2424@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shashi Mawar 
Designation  Associate professor 
Affiliation  College Of Nursing, AIIMS Delhi 
Address  room no 4, Pota cabin 2, 2nd floor, College of Nursing, AIIMS New Delhi 110049

South
DELHI
110049
India 
Phone  8800228317  
Fax    
Email  drshashimawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Satarupa Sarkar 
Designation  M.Sc. Nursing Student 
Affiliation  College Of Nursing, AIIMS Delhi 
Address  Pota cabin 2, 2nd floor, College of Nursing, AIIMS New Delhi 110029

South
DELHI
110049
India 
Phone  09679281700  
Fax    
Email  satarupa.sarkar2424@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  Pota cabin 2, 2nd floor, College of Nursing AIIMS Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashi Mawar  All India Institute of Medical Sciences New Delhi  mother and child block, ground floor, Obstetrics and gynecology OPD
South
DELHI 		 8800228317

drshashimawar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029  Approved 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1 Females aged 18–40years.
2 Women who had a clinical diagnosis of PCOS based on medical evaluation.
3 Women who give consent to participate in the study.
 
 
ExclusionCriteria 
Details  1 Pregnancy or lactation.
2 Use of medications which has an effect in metabolic parameters
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to identify risk factors  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size
Modification(s)  		 Total Sample Size="142"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [satarupa.sarkar2424@gmail.com].

  6. For how long will this data be available start date provided 30-11-2026 and end date provided 19-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A case control study will be conducted to assess the prevalence of metabolic syndrome among females with PCOS in tertiary care hospital in India. This study aims to assess the prevalence of metabolic syndrome in women with PCOS and explore the metabolic risk factors compared to non-PCOS controls. Population of the study will be females diagnosed with PCOS for case group and general population not diagnosed with  PCOS for control group. The data collection process for a PCOS study. It involves recruiting women with PCOS and age-matched controls, obtaining informed consent, and collecting detailed information. This includes demographic data, reproductive history, lifestyle factors, and family history. Physical measurements like weight, height, and waist circumference are taken, along with blood pressure and blood samples for biochemical analysis. Finally, participants are assessed for metabolic syndrome based on established criteria. 
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